Perioperative Methadone Compared to Placebo in Elderly Hip Fracture Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Consumption of daily morphine equivalents 3 days post operatively
研究概览
简要总结
Hip fractures are associated with severe pain and are sustained by the elderly population. Demand for adequate pain relief combined with a low tolerance for analgesic drugs makes the treatment of elderly hip fracture patients difficult. Perioperative methadone could improve the analgesic treatment of these patients. An earlier pilot study showed that 0.10 mg/kg was safe to use. This study further investigates the advantages of methadone. The study's objective is to investigate the analgesic effects of a single dose of methadone given during hip fracture surgery.
详细描述
Studies investigating the perioperative use of methadone have shown promising analgesic properties. Our pilot study (EudraCT no.: 2022-001857-22) showed that a dosage of 0.10 mg/kg was safe to use and showed excellent analgesic properties. Sufficient management of acute postoperative pain is important in relation to morbidity, hospital costs, and mortality. About 60% of patients undergoing surgical intervention experience moderate to severe postoperative pain. Thus, sufficient analgesic treatment is crucial in the initial postoperative days, which are considered the most painful phase of recovery. Opioids have conventionally been used as an analgesic treatment in this phase. However, this treatment has been accompanied by side effects and addiction. Methadone shares these side effects, however, as methadone only needs to be administered once, the risk of side effects decreases significantly. This study will investigate the analgesic effects of a single dose of methadone given during hip fracture surgery.
The first objective is to investigate the analgesic effect of perioperative methadone compared with a placebo in acute hip fracture surgery. The second objective is to investigate the long-term effects of methadone on continued opioid consumption, pain, and mobility three months after surgery.
The null hypothesis is that there is no difference in postoperative pain, opioid consumption, or related side effects if a patient receives a dose of methadone or placebo during the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with an acute hip fracture (incurred <24 hours ago) on x-rays in the emergency department (ED) at the university hospital of southern Denmark (SHS). This includes collum femoris fractures, pertrochanteric fractures, and subtrochanteric fractures.
- •Patients must be able to read and understand Danish.
排除标准
- •Multiple fractures or multi-trauma patient
- •Previous allergic reactions or hypersensitivity towards methadone hydrochloride or sodium chloride
- •Health conditions preventing treatment:
- •Chronic obstructive pulmonary disease with either past exacerbations or daily symptoms History of acute asthma attacks History of drug-induced eczema Pulmonary hypertension Raised intracranial pressure or recent head injury Pheochromocytoma History of paralytic ileus QT-interval prolongation on electrocardiogram (ECG) Myasthenia gravis Known liver disorder Hypotension (systolic blood pressure <100 mmHg at admission) Acute pancreatitis Severe kidney disease (GFR ≤10)
- •Concurrent administration with MAO inhibitors or within 2 weeks of suspending treatment with these medicinal products
- •Concurrent administration of benzodiazepines
- •Impaired cognitive function e.g. dementia. Patients must be able to give informed consent and be able to ask for rescue analgesics if needed
- •Current opioid addiction or intravenous addiction
研究组 & 干预措施
Methadone
Methadone hydrochloride (0.10 mg/kg) administered intravenously at the induction of anaesthesia
干预措施: Methadone Hydrochloride (Drug)
Placebo
Standard saline solution administered intravenously at the induction of anaesthesia
干预措施: Placebo (Other)
结局指标
主要结局
Consumption of daily morphine equivalents 3 days post operatively
时间窗: 3 days post-surgery
All opioids (short-acting and long-acting) will be converted into daily morphine milligram equivalent doses. The amount of opioids used by the patient within the last 24 hours will be registered daily. A minimum amount of 0 mg and a maximum amount of 150 mg can be recorded.
Consumption of daily morphine equivalents 3 months post operatively
时间窗: 3 months post-surgery
The opioid consumption will be registered as a mean daily consumption of both long-acting opioids and rescue medication prescribed in the medication chart and reported by the patient. Different types of opioids will be converted into the daily morphine milligram equivalent dose. Minimum score will be 0 mg and the maximum will be 150 mg.
次要结局
- Number of days to discharge after surgery(From admission to the ward to discharge, up to 14 days)
- Patient mobility assessed using the new mobility score (NMS)(3 months post-surgery)
- Postoperative pain assessment with verbal rating scale (VRS)(3 months post-surgery)
- Quality of life assessed using EQ-5D-5L questionnaire(3 months post-surgery)
- Number of persistent side effects(3 months post-surgery)
- Mobility assessment using the Cumulated Ambulation Score (CAS)(3 days post-surgery)
- Number of patients with post operative nausea or vomiting (PONV)(3 days post-surgery)
- Number of patients requiring an antidote(3 days post-surgery)
- Number of participants with constipation(3 days post-surgery)
- Time until patient first stands up post-surgery(up to 72 hours post-surgery)
- Number of patients with delirium assessed using the Confusion Assessment Method (CAM)(3 days post-surgery)